A federal jury cleared Bayer AG and Johnson & Johnson of liability in the second trial to stem from thousands of lawsuits blaming injuries on the blood thinner Xarelto, the drug companies said.
U.S. officials have given a green light for two clinical trials testing AstraZeneca’s cancer immunotherapy drug durvalumab in head and neck cancer to resume recruiting patients, lifting a hold imposed following cases of bleeding.
Portola Pharmaceuticals announced that the U.S. Food and Drug Administration rejected its AndexXa to treat life-threatening or uncontrolled bleeding.
The U.S. Food and Drug Administration on Tuesday approved Baxalta Inc’s Vonvendi, making it the first engineered protein-based treatment for the world’s most common inherited bleeding disorder. Vonvendi treats Willebrand disease, which is caused by the deficiency or defect in von Willebrand factor, a protein that is critical for blood clotting. The disease affects about […]
The U.S. Food and Drug Administration said on Friday it approved Baxalta Inc’s drug for use in patients with a type of rare bleeding disorder. The drug, Adynovate, was approved to control and reduce the frequency of bleeding episodes in patients with Hemophilia A, the agency said in a statement. Data from a late-stage study, […]
A drug developed by Portola Pharmaceuticals to rapidly reverse the effect of new blood thinning agents in cases of major bleeding or other emergencies proved highly effective in a late stage study, according to data presented on Wednesday that should help make the case for its approval. Portola’s andexanet alfa reversed the anticoagulant effect of […]
RIDGEFIELD, Conn., Oct. 16, 2015 /PRNewswire/ — Boehringer Ingelheim Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) granted approval of Praxbind® (idarucizumab). PRAXBIND is indicated for patients treated with Pradaxa® (dabigatran etexilate mesylate), when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding. […]
Nestle is working with Lipid Therapeutics to develop and commercialize a new therapeutic treatment for mild-to-moderate ulcerative colitis, which can causes ulcers, bleeding and pain due to inflammation of the colon, the company said on Wednesday. Nestle Health Science intends to develop an add-on therapy to an existing one that is commonly used but with […]
Global evidence from EXPLORER research program reports real-world bleeding rates in XARELTO® (rivaroxaban) patients with non-valvular atrial fibrillation LONDON, Sept. 1, 2015 /PRNewswire/ — Janssen Pharmaceuticals, Inc., and its development partner, Bayer HealthCare, today announced results from PMSS (Post-Marketing Safety Surveillance) and XANTUS (XARELTO® for Prevention of Stroke in Patients with Atrial Fibrillation), their […]